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Fresenius Noninvasive Blood Pressure Validation

NCT04573595 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2021-02-02

No results posted yet for this study

Summary

The purpose of this study to collect blood pressure measurement values from the blood pressure measurement device on the Fresenius machine as compared to the standard method.

Conditions

  • Blood Pressure

Interventions

DEVICE

Blood Pressure Measurement

The purpose of this study is to provide supporting documentation for Noninvasive blood pressure measurement accuracy claims for Fresenius 5008S BPM Module and Cuffs on the intended population(s). The same arm sequential method with dual observer auscultation will be used to collect data.

Sponsors & Collaborators

  • Fresenius Medical Care North America

    lead INDUSTRY

Principal Investigators

  • Arthure Cabrera, MD · Avista Adventist Hosptial, Staff Anesthesiologist

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
13 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-17
Primary Completion
2020-12-04
Completion
2020-12-04
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04573595 on ClinicalTrials.gov